Search
![](https://static.wixstatic.com/media/nsplsh_a7006c204eb84137a9479de050c3b977~mv2.jpg/v1/fill/w_250,h_250,fp_0.50_0.50,q_30,blur_30,enc_auto/nsplsh_a7006c204eb84137a9479de050c3b977~mv2.jpg)
![USFDA Guidance: Cancer Clinical Trial Eligibility Criterias](https://static.wixstatic.com/media/nsplsh_a7006c204eb84137a9479de050c3b977~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_a7006c204eb84137a9479de050c3b977~mv2.jpg)
Sharan Murugan
- Apr 27
- 2 min
USFDA Guidance: Cancer Clinical Trial Eligibility Criterias
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence, Center for Drug Evaluation and Research, and Center for...
7 views0 comments
![](https://static.wixstatic.com/media/nsplsh_71777443654a35634c5973~mv2_d_2947_2121_s_2.jpg/v1/fill/w_250,h_250,fp_0.50_0.50,q_30,blur_30,enc_auto/nsplsh_71777443654a35634c5973~mv2_d_2947_2121_s_2.jpg)
![USFDA Guidance: Submitting Patient-Reported Outcome Data, Clinical Trial Datasets & Documentation](https://static.wixstatic.com/media/nsplsh_71777443654a35634c5973~mv2_d_2947_2121_s_2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_71777443654a35634c5973~mv2_d_2947_2121_s_2.jpg)
Sharan Murugan
- Nov 6, 2023
- 2 min
USFDA Guidance: Submitting Patient-Reported Outcome Data, Clinical Trial Datasets & Documentation
Today (06 November, 2023) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) released two final...
16 views0 comments
![](https://static.wixstatic.com/media/nsplsh_4fb4c52572dd4b1b869cee3f1d88eef0~mv2.jpg/v1/fill/w_250,h_250,fp_0.50_0.50,q_30,blur_30,enc_auto/nsplsh_4fb4c52572dd4b1b869cee3f1d88eef0~mv2.jpg)
![USFDA Guidance: Selective Approach to Safety Data Collection & Dosing Regimens of PD1 & PD-L1](https://static.wixstatic.com/media/nsplsh_4fb4c52572dd4b1b869cee3f1d88eef0~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_4fb4c52572dd4b1b869cee3f1d88eef0~mv2.jpg)
Sharan Murugan
- Dec 6, 2022
- 1 min
USFDA Guidance: Selective Approach to Safety Data Collection & Dosing Regimens of PD1 & PD-L1
Earlier today USFDA's Center for Drug Evaluation and Research (CDER) & Oncology Center of Excellence released the updated final guidance...
8 views0 comments
![](https://static.wixstatic.com/media/nsplsh_7967315a61796e30466577~mv2.jpg/v1/fill/w_250,h_250,fp_0.50_0.50,q_30,blur_30,enc_auto/nsplsh_7967315a61796e30466577~mv2.jpg)
![Draft Guidance on PK-Based Criteria for Alternative Dosing Regimens for Treatment of Cancer - USFDA](https://static.wixstatic.com/media/nsplsh_7967315a61796e30466577~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_7967315a61796e30466577~mv2.jpg)
Sharan Murugan
- Aug 30, 2021
- 1 min
Draft Guidance on PK-Based Criteria for Alternative Dosing Regimens for Treatment of Cancer - USFDA
On 25th August 2021, the Oncology Center of Excellence along with the Center for Drug Evaluation and Research released new draft guidance...
8 views0 comments
![](https://static.wixstatic.com/media/6516fb_d2844f107f4e433f864a6c02f415a519~mv2.jpg/v1/fill/w_250,h_250,fp_0.50_0.50,q_30,blur_30,enc_auto/6516fb_d2844f107f4e433f864a6c02f415a519~mv2.jpg)
![Guidance on Metastasis-Free Survival as an Endpoint - Prostate Cancer trials – USFDA](https://static.wixstatic.com/media/6516fb_d2844f107f4e433f864a6c02f415a519~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/6516fb_d2844f107f4e433f864a6c02f415a519~mv2.jpg)
Sharan Murugan
- Aug 8, 2021
- 1 min
Guidance on Metastasis-Free Survival as an Endpoint - Prostate Cancer trials – USFDA
USFDA on 06-July-2021, finalized guidance on the use of metastasis-free survival (MFS) as an endpoint in clinical trials for...
12 views0 comments